Risk Assessment Report on sodium hypochlorite Human Health Part. CAS No.: EINECS No

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Risk Assessment Report on sodium hypochlorite Human Health Part. CAS No.: EINECS No"

Transcription

1 Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on sodium hypochlorite Human Health Part CAS No.: EINECS No The SCHER adopted this opinion at its 21 st plenary on 15 January 2008

2 About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Products (SCCP), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) and are made up of external experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Evaluation Agency (EMEA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCHER Questions relating to examinations of the toxicity and ecotoxicity of chemicals, biochemicals and biological compound whose use may have harmful consequences for human health and the environment. In particular, the Committee addresses questions related to new and existing chemicals, the restriction and marketing of dangerous substances, biocides, waste, environmental contaminants, plastic and other materials used for water pipe work (e.g. new organics substances), drinking water, indoor and ambient air quality. It addresses questions relating to human exposure to mixtures of chemicals, sensitisation and identification of endocrine disrupters. Scientific Committee members Herman Autrup, Peter Calow, Wolfgang Dekant, Helmut Greim, Hanke Wojciech, Colin Janssen, Bo Jansson, Hannu Komulainen, Ole Ladefoged, Jan Linders, Inge Mangelsdorf, Marco Nuti, Jerzy Sokal, Anne Steenhout, Jose Tarazona, Emanuela Testai, Marco Vighi, Matti Viluksela Contact: European Commission Health & Consumer Protection DG Directorate C: Public Health and Risk Assessment Unit C7 - Risk Assessment Office: B232 B-1049 Brussels European Commission 2008 The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. 2

3 ACKNOWLEDGMENTS The rapporteur is acknowledged for his valuable contribution to this opinion: Prof. W. Dekant Universität Würzburg, Germany Keywords: SCHER, scientific opinion, risk assessment, Regulation 793/93, Sodium hypochlorite, human health, CAS Opinion to be cited as: SCHER, scientific opinion on the risk assessment report on Sodium hypochlorite, CAS , human health part, 15 January

4 TABLE OF CONTENTS ACKNOWLEDGMENTS BACKGROUND TERMS OF REFERENCE OPINION General comments Specific comments Exposure assessment Effect assessment Risk characterisation LIST OF ABBREVIATIONS

5 1. BACKGROUND Council Regulation 793/93 provides the framework for the evaluation and control of the risk of existing substances. Member States prepare Risk Assessment Reports on priority substances. The Reports are then examined by the Technical Committee under the Regulation and, when appropriate, the Commission invites the Scientific Committee on Health and Environmental Risks (SCHER) to give its opinion. 2. TERMS OF REFERENCE On the basis of the examination of the Risk Assessment Report the SCHER is invited to examine the following issues: (1) Does the SCHER agree with the conclusions of the Risk Assessment Report? (2) If the SCHER disagrees with such conclusions, it is invited to elaborate on the reasons. (3) If the SCHER disagrees with the approaches or methods used to assess the risks, it is invited to suggest possible alternatives. 3. OPINION 3.1 General comments The health part of the document is of good quality, it is comprehensive, and the exposure and effects assessment follow the Technical Guidance Document. The RAR covers all studies relevant for exposure and hazard assessment of sodium hypochlorite and also includes information on the toxicology of chlorine when considered necessary. In aqueous solution, which is the major form of application for hypochlorite, a phdependent equilibrium between chlorine, hypochloric acid and hypochlorite is present. At the ph (9 13) of commercial solutions of hypochlorite, the predominant species is hypochloric acid. Chlorine can only be released when hypochlorite solutions are mixed with strong acids. 3.2 Specific comments Exposure assessment The RAR contains a number of detailed exposure assessments for the known uses of sodium hypochlorite solutions. The assessments performed and the parameters used are well justified. The occupational exposure assessments conclude that dermal contact with sodium hypochlorite solutions used for disinfection/cleaning purposes are the major routes of exposure. Regarding consumers, dermal contact during use of sodium hypochlorite solutions for cleaning and dermal contact and oral ingestion of diluted sodium hypochlorite from swimming pools after water chlorination may occur. In addition, chlorinated drinking water is a source for sodium hypochlorite exposures of the general population. SCHER agrees that indirect exposure via the environment and combined exposure scenarios are not of concern regarding sodium hypochlorite. 5

6 3.2.2 Effect assessment The irritation and corrosive properties of concentrated sodium hypochlorite solutions is well described, a number of studies also support the conclusion that sodium hypochlorite is not a sensitizer. SCHER also considers the assumption of a 10 % dermal bioavailability as reasonable due to the low lipid solubility of sodium hypochlorite. Regarding repeated-dose toxicity, a number of studies are available for evaluation and SCHER agrees with NOAELs and NOAECs derived from the evaluation of these studies. Regarding mutagenicity and carcinogenicity, SCHER agrees that additional testing for mutagenicity is not required despite an inconclusive database for mutagenicity since negative carcinogenicity studies for oral consumption of sodium hypochlorite solutions are available. SCHER also agrees that carcinogenicity is not a relevant endpoint regarding oral exposures to sodium hypochlorite due to the availability of negative carcinogenicity studies in animals and inconclusive epidemiology studies on consumption of chlorinated drinking water and cancer incidence in humans. SCHER also supports the conclusion that there is no evidence for developmental or reproductive toxicity of sodium hypochlorite based on the available database on hypochloride and chlorine Risk characterisation The risk characterization performed in the RAR uses the margin-of-safety (MOS) approach and is performed for oral, inhalation and dermal exposures of consumers and dermal and inhalation exposures of workers. SCHER agrees with conclusions ii) 1 for all exposure scenarios due to high MOS. 4. LIST OF ABBREVIATIONS MOS NOAEC NOAEL RAR TGD Margin of Safety No Observed Adverse Effect Concentration No Observed Adverse Effect Level Risk Assessment Report Technical Guidance Document 1 According to the Technical Guidance Document on Risk Assessment European Communities 2003: - conclusion i): There is a need for further information and/or testing; - conclusion ii): There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already; - conclusion iii): There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. 6

Risk Assessment Report on Chlorine. Human Health Part. CAS No.: EINECS No

Risk Assessment Report on Chlorine. Human Health Part. CAS No.: EINECS No Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Chlorine Human Health Part CAS No.: 7782-50-5 EINECS No. 231-959-5 The SCHER adopted this opinion at its 22 nd plenary

More information

Opinion on. Risk Assessment Report on NITROBENZENE. Human Health Part. CAS No: EINECS No:

Opinion on. Risk Assessment Report on NITROBENZENE. Human Health Part. CAS No: EINECS No: Scientific Committee on Health and Environmental Risks SCHER Opinion on Risk Assessment Report on NITROBENZENE Human Health Part CAS No: 98-95-3 EINECS No: 202-95-3 The SCHER adopted this opinion at its

More information

Risk Assessment Report on Hexachlorocyclopentadiene (HCCP) Human Health Part. CAS No.: EINECS No.:

Risk Assessment Report on Hexachlorocyclopentadiene (HCCP) Human Health Part. CAS No.: EINECS No.: Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Hexachlorocyclopentadiene (HCCP) Human Health Part CAS No.: 77-47-4 EINECS No.: 201-029-3 The SCHER adopted this opinion

More information

Opinion on. Risk Assessment Report on TETRACHLOROETHYLENE Human Health Part. CAS No.: EINECS No

Opinion on. Risk Assessment Report on TETRACHLOROETHYLENE Human Health Part. CAS No.: EINECS No Scientific Committee on Health and Environmental Risks SCHER Opinion on Risk Assessment Report on TETRACHLOROETHYLENE Human Health Part CAS No.: 127-18-4 EINECS No. 204-825-9 The SCHER adopted this opinion

More information

Opinion on Voluntary Risk Assessment Report on lead and lead compounds. Human Health Part

Opinion on Voluntary Risk Assessment Report on lead and lead compounds. Human Health Part Scientific Committee on Health and Environmental Risks SCHER Opinion on Voluntary Risk Assessment Report on lead and lead compounds Human Health Part CAS No: 7439-92-1, 1317-36-8, 1314-41-6, 69011-06-9,

More information

Risk Assessment Report on styrene. Human Health Part

Risk Assessment Report on styrene. Human Health Part Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on styrene Human Health Part CAS No.: 100-42-6 EINECS no.: 202-851-5 SCHER adopted this opinion at its 23 rd plenary

More information

Risk Assessment Report on. Bis(hydroxylammonium)sulfate. CAS No.: EINECS no.:

Risk Assessment Report on. Bis(hydroxylammonium)sulfate. CAS No.: EINECS no.: Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Bis(hydroxylammonium)sulfate CAS No.: 10039-54-0 EINECS no.: 233-118-8 The SCHER adopted this opinion at its 21 st

More information

Risk Assessment Report on Vinyl acetate. Human Health Part. CAS No.: EINECS No.:

Risk Assessment Report on Vinyl acetate. Human Health Part. CAS No.: EINECS No.: Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Vinyl acetate Human Health Part CAS No.: 108-05-4 EINECS No.: 203-545-4 The SCHER adopted this opinion at its 26 th

More information

Risk Assessment Report on Alkanes, C 14-17, chloro MCCP. Human Health Part. CAS No.: EINECS no.:

Risk Assessment Report on Alkanes, C 14-17, chloro MCCP. Human Health Part. CAS No.: EINECS no.: Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Alkanes, C 14-17, chloro MCCP Human Health Part CAS No.: 85535-85-9 EINECS no.: 287-477-0 The SCHER adopted this opinion

More information

Risk Assessment Report on Diphenylamine. Human Health Part. CAS No.: EINECS No.:

Risk Assessment Report on Diphenylamine. Human Health Part. CAS No.: EINECS No.: Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Diphenylamine Human Health Part CAS No.: 122-39-4 EINECS No.: 204-539-4 The SCHER adopted this opinion at its 21 st

More information

Assessment of the Health Risks from the Use of Metallic Nickel (CAS No ) in Toys

Assessment of the Health Risks from the Use of Metallic Nickel (CAS No ) in Toys Scientific Committee on Health and Environmental Risks SCHER Assessment of the Health Risks from the Use of Metallic Nickel (CAS No 7440-02-0) in Toys The SCHER adopted this opinion at its 17 th plenary

More information

TARGETED RISK ASSESSMENT REPORT ON SODIUM HYDROXIDE (NAOH) HUMAN HEALTH PART. CAS No.: ; EINECS No.:

TARGETED RISK ASSESSMENT REPORT ON SODIUM HYDROXIDE (NAOH) HUMAN HEALTH PART. CAS No.: ; EINECS No.: TARGETED RISK ASSESSMENT REPORT ON SODIUM HYDROXIDE (NAOH) HUMAN HEALTH PART CAS No.: 1310-73-2; EINECS No.: 215-185-5 Opinion adopted by the SCHER during the 14 th plenary of 30 November 2006 ACKNOWLEDGEMENTS

More information

Risk Assessment Report on Tris (nonylphenyl)phosphite (TNPP)

Risk Assessment Report on Tris (nonylphenyl)phosphite (TNPP) EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Public Health and Risk Assessment C7 - Risk assessment SCIENTIFIC COMMITTEE ON HEALTH AND ENVIRONMENTAL RISKS SCHER

More information

Clarification on the Opinions SCCNFP/0653/03 and SCCP/0882/05

Clarification on the Opinions SCCNFP/0653/03 and SCCP/0882/05 Scientific Committee on Consumer Products SCCP Clarification on the Opinions SCCNFP/0653/03 and SCCP/0882/05 on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6

More information

Risk Assessment Report on Zinc. Environmental Part

Risk Assessment Report on Zinc. Environmental Part Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Zinc Environmental Part Zinc metal (CAS No. 7440-66-6, EINECS No. 231-175-3) Zinc oxide (CAS No. 1314-13-2, EINECS

More information

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) Opinion on the results of the Risk Assessment of:

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) Opinion on the results of the Risk Assessment of: EUROPEAN COMMISSION DIRECTORATE-GENERAL HEALTH AND CONSUMER PROTECTION Directorate C - Scientific Opinions Unit C2 Management of Scientific Committees; scientific co-operation and networks Scientific Committee

More information

Scientific Committee on Consumer Products SCCP OPINION ON. Toluene. (its use as a solvent in nail cosmetics)

Scientific Committee on Consumer Products SCCP OPINION ON. Toluene. (its use as a solvent in nail cosmetics) Scientific Committee on Consumer Products SCCP OPINION ON Toluene (its use as a solvent in nail cosmetics) The SCCP adopted this opinion at its 15 th plenary of 15 April 2008 About the Scientific Committees

More information

Draft OPINION ON. Use of the Threshold of Toxicological Concern (TTC) Approach for the Safety Assessment of Chemical Substances

Draft OPINION ON. Use of the Threshold of Toxicological Concern (TTC) Approach for the Safety Assessment of Chemical Substances SCCP/1171/08 Scientific Committee on Consumer Products (SCCP) Scientific Committee on Health and Environmental Risks (SCHER) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)

More information

HYDROGEN PEROXIDE HUMAN HEALTH EFFECTS. CAS No.: EINECS No.: REPORT VERSION: Draft of 24 April 2001

HYDROGEN PEROXIDE HUMAN HEALTH EFFECTS. CAS No.: EINECS No.: REPORT VERSION: Draft of 24 April 2001 EUROPEAN COMMISSION DIRECTORATE-GENERAL HEALTH AND CONSUMER PROTECTION Directorate C - Scientific Opinions Unit C2 - Management of Scientific Committees; scientific co-operation and networks Scientific

More information

Risk Assessment Terminology, Expression of Nature and level of Risk and Uncertainties

Risk Assessment Terminology, Expression of Nature and level of Risk and Uncertainties Risk Assessment Terminology, Expression of Nature and level of Risk and Uncertainties Professor Tony Hardy, Chair of EFSA PPR Panel Brussels 13 th November 2008 Comparative Review of Risk Terminology of

More information

TRIS (NONYLPHENYL) PHOSPHITE SUMMARY RISK ASSESSMENT REPORT

TRIS (NONYLPHENYL) PHOSPHITE SUMMARY RISK ASSESSMENT REPORT TRIS (NONYLPHENYL) PHOSPHITE CAS-No.: 26523-78-4 EINECS-No.: 247-759-6 SUMMARY RISK ASSESSMENT REPORT Final report, 2007 France Rapporteur for the risk assessment of tris(nonylphenyl) phosphite is the

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Active chlorine released from calcium hypochlorite Product type: 4 ECHA/BPC/134/2016 Adopted 14 December

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: L(+) lactic acid Product type: 2 ECHA/BPC/147/2017 Adopted 27 April 2017 Annankatu 18, P.O. Box 400, FI-00121

More information

FÜR RISIKOBEWERTUNG BUNDESINSTITUT

FÜR RISIKOBEWERTUNG BUNDESINSTITUT BUNDESINSTITUT FÜR RISIKOBEWERTUNG Legal and Practical Aspects of the Cut-off Criteria for Reproductive Toxic and Endocrine Disrupting Effects for Approval and Classification of Pesticides in Europe Roland

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Hydrated lime Product type: 2 ECHA/BPC/100/2016 Adopted 14 April 2016 Annankatu 18, P.O. Box 400, FI-00121

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Hydrated lime Product type: 3 ECHA/BPC/101/2016 Adopted 14 April 2016 Annankatu 18, P.O. Box 400, FI-00121

More information

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C Public Health and Risk Assessment C7 Risk assessment Brussels, C7/VR/csteeop/Cr/100903 D(03) SCIENTIFIC COMMITTEE ON TOXICITY,

More information

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL. Joint meetrag of the Earopean Commission Scieatäfíc Committees and the Еигореав

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL. Joint meetrag of the Earopean Commission Scieatäfíc Committees and the Еигореав Ref. Ares(2012)123978-03/02/2012 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate D - Public Health and Risk Assessment Unit D5 - Risk Assessment Brussels, 11 July 2011

More information

Trisodium nitrilotriacetate (NTA)

Trisodium nitrilotriacetate (NTA) RISK MANAGEMENT OPTIONS ANALYSIS CONCLUSION DOCUMENT for Trisodium nitrilotriacetate (NTA) EC No 225-768-6 CAS No 5064-31-3 Member State: Denmark Dated: August 2014, Final version Disclaimer: Please note

More information

HUMAN HEALTH RISK ASSESSMENT FOR METALLIC CHROMIUM AND TRIVALENT CHROMIUM IN ACCORDANCE WITH EUROPEAN UNION LEGISLATION

HUMAN HEALTH RISK ASSESSMENT FOR METALLIC CHROMIUM AND TRIVALENT CHROMIUM IN ACCORDANCE WITH EUROPEAN UNION LEGISLATION HUMAN HEALTH RISK ASSESSMENT FOR METALLIC CHROMIUM AND TRIVALENT CHROMIUM IN ACCORDANCE WITH EUROPEAN UNION LEGISLATION M. Luotamo and V. Riihimäki Unit of Toxicological Risk Assessment, FIOH, Finnish

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Hydrated dolomitic lime Product type: 2 ECHA/BPC/102/2016 Adopted 14 April 2016 Annankatu 18, P.O. Box

More information

Human health effects of antimony an update

Human health effects of antimony an update Human health effects of antimony an update Dr. R.V. Battersby EBRC Consulting GmbH Karine Van de Velde i2a Secretary General Raffaelstr. 4 30177 Hannover Germany Public perception of HH effects of antimony

More information

Official Journal of the European Union

Official Journal of the European Union 1.6.2016 L 144/27 COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,

More information

Pesticide risk assessment: changes and perspectives for mammalian toxicology in the new EC regulation 1107/2009

Pesticide risk assessment: changes and perspectives for mammalian toxicology in the new EC regulation 1107/2009 Pesticide risk assessment: changes and perspectives for mammalian toxicology in the new EC regulation 1107/2009 M.Tiramani Pesticide Risk Assessment Peer Review (PRAPeR) Mammalian toxicology New Pesticide

More information

PRODUCT INFORMATION SHEET

PRODUCT INFORMATION SHEET PRODUCT INFORMATION SHEET FEATURES & APPLICATIONS FOOD SAFE SANITISER Unico Limited, North Main Street, Carronshore, Falkirk. FK2 8HT Tel: 0845 27 86426 Fax: 01324 573401 Unico Food Safe Sanitiser is a

More information

COMMISSION REGULATION (EU)

COMMISSION REGULATION (EU) 11.3.2011 Official Journal of the European Union L 64/15 COMMISSION REGULATION (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: OIT Product type: 8 ECHA/BPC/139/2016 Adopted 15 December 2016 Annankatu 18, P.O. Box 400, FI-00121 Helsinki,

More information

Benzothiazole-2-thiol (2-MBT)

Benzothiazole-2-thiol (2-MBT) SUBSTANCE EVALUATION CONCLUSION DOCUMENT as required by REACH Article 48 for Benzothiazole-2-thiol (2-MBT) EC No 205-736-8 CAS No 149-30-4 Evaluating Member State(s): Germany Dated: 17 March 2014 Evaluating

More information

Methodologies for development of human health criteria and values for the lake Erie drainage basin.

Methodologies for development of human health criteria and values for the lake Erie drainage basin. 3745-1-42 Methodologies for development of human health criteria and values for the lake Erie drainage basin. [Comment: For dates of non-regulatory government publications, publications of recognized organizations

More information

TNsG on Annex I Inclusion Revision of Chapter 4.1: Quantitative Human Health Risk Characterisation

TNsG on Annex I Inclusion Revision of Chapter 4.1: Quantitative Human Health Risk Characterisation TNsG on Annex I Inclusion Revision of Chapter 4.1: Quantitative Human Health Risk Characterisation These Technical Notes for Guidance were adopted during the 34 th meeting of representatives of Members

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Salicylic acid Product type: 4 ECHA/BPC/189/2018 6 March 2018 Annankatu 18, P.O. Box 400, FI-00121 Helsinki,

More information

Risk Assessment to Risk Management Terminology of Risk Assessment. EFSA Project on Risk Assessment Terminology

Risk Assessment to Risk Management Terminology of Risk Assessment. EFSA Project on Risk Assessment Terminology Risk Assessment to Risk Management Terminology of Risk Assessment EFSA Project on Risk Assessment Terminology Professor Tony Hardy, Chair of the Panel on Plant Protection Products and their Residues 2

More information

Step by Step Approach for GPS Risk Assessment

Step by Step Approach for GPS Risk Assessment Step by Step Approach for GPS Risk Assessment 1) Tier Categorization and Prioritization 2) Hazard Characterization By Mr. Krittanon Yuen-ying (Product Regulatory) Dow Chemical Thailand Limited Email: krittanon.yuen-ying@dow.com

More information

Human Health Risk Assessment Overview [For the APS/OPP Roundtable]

Human Health Risk Assessment Overview [For the APS/OPP Roundtable] Human Health Risk Assessment Overview [For the APS/OPP Roundtable] Christina Swartz, USEPA Nov. 12, 2008 [Slides Courtesy of Mike Metzger, USEPA] The Risk Assessment Paradigm: The Red Book Hazard Identification

More information

Part 2. Chemical and physical aspects

Part 2. Chemical and physical aspects Part 2. Chemical and physical aspects 12. Chemical and physical aspects: introduction 12.1 Background information used The assessment of the toxicity of drinking-water contaminants has been made on the

More information

GHS data for solutions

GHS data for solutions GHS data for solutions Experimental data for solutions are available for relatively few chemicals, apart from the most common industrial chemicals, such as sodium hydroxide and sulfuric acid. In the absence

More information

Questions and Answers on Candidates for Substitution

Questions and Answers on Candidates for Substitution Questions and Answers on Candidates for Substitution Rev. 1, January 2015 Background The European Commission is required by Regulation (EC) No 1107/2009 ( the Regulation ) to establish a list of substances

More information

Room: 0D Centre Albert Borschette Rue Froissart Brussels, Belgium

Room: 0D Centre Albert Borschette Rue Froissart Brussels, Belgium EUROPEAN COMMISSION ENVIRONMENT DIRECTORATE-GENERAL Circular Economy and Green Growth Sustainable Chemicals DIRECTORATE-GENERAL INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMES Consumer, Environmental

More information

Biocidal Products Committee (BPC)

Biocidal Products Committee (BPC) Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Salicylic acid Product type: 2 ECHA/BPC/187/2018 6 March 2018 Annankatu 18, P.O. Box 400, FI-00121 Helsinki,

More information

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) Minutes of the. 29th PLENARY MEETING

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) Minutes of the. 29th PLENARY MEETING 09.01.2002 EUROPEAN COMMISSION DIRECTORATE-GENERAL HEALTH AND CONSUMER PROTECTION Directorate C - Scientific Opinions Unit C2 - Management of Scientific Committees; scientific co-operation and networks

More information

ECPA position paper on the criteria for the determination of endocrine disrupting properties under Regulation

ECPA position paper on the criteria for the determination of endocrine disrupting properties under Regulation POSITION PAPER 09/06/2016 PP/14/PD/23734 ECPA position paper on the criteria for the determination of endocrine disrupting properties under Regulation The European Commission is currently developing new

More information

Substance Evaluation Conclusion document EC No SUBSTANCE EVALUATION CONCLUSION DOCUMENT. as required by REACH Article 48.

Substance Evaluation Conclusion document EC No SUBSTANCE EVALUATION CONCLUSION DOCUMENT. as required by REACH Article 48. SUBSTANCE EVALUATION CONCLUSION DOCUMENT as required by REACH Article 48 for Butanone oxime EC No 202-496-6 CAS No 96-29-7 Evaluating Member State(s): Germany Dated: 18 March 2014 Evaluating Member State

More information

SAFETY DATA SHEET Clinell Antibacterial Hand Wipes According to Regulation (EU) No 453/2010

SAFETY DATA SHEET Clinell Antibacterial Hand Wipes According to Regulation (EU) No 453/2010 SECTION 1: Identification of the substance/mixture and company/undertaking 1.1 Product Identifier Product Name 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified

More information

Please find below the Commission Communication and the Commission Recommendation for the substance zinc sulphate

Please find below the Commission Communication and the Commission Recommendation for the substance zinc sulphate Please find below the Commission Communication and the Commission Recommendation for the substance zinc sulphate CAS No: 7733-02-0 EINECS No: 231-793-3 20.6.2008 EN C 155/1 II (Information) INFORMATION

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON USER SAFETY FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON USER SAFETY FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS European Medicines Agency Veterinary Medicines and Inspections London, 23 April 2007 Doc. Ref. EMEA/CVMP/IWP/54533/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON USER SAFETY

More information

DRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX

DRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX EUROPEAN COMMISSION Brussels, XXX C(2016) 3752 projet DRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX setting out scientific criteria for the determination of endocrine-disrupting properties pursuant

More information

Non surfactant Organic Ingredients and Zeolite-based Detergents

Non surfactant Organic Ingredients and Zeolite-based Detergents Scientific Committee on Health and Environmental Risks SCHER Non surfactant Organic Ingredients and Zeolite-based Detergents (RPA report J480b/detergents 30 June 2006) The SCHER adopted this opinion at

More information

PRODUCT INFORMATION SHEET

PRODUCT INFORMATION SHEET PRODUCT INFORMATION SHEET FEATURES & APPLICATIONS FOOD SAFE SANITISER Unico Limited, North Main Street, Carronshore, Falkirk. FK2 8HT Tel: 0845 27 86426 Fax: 01324 573401 Unico Food Safe Sanitiser is a

More information

Substance Evaluation Conclusion document EC No SUBSTANCE EVALUATION CONCLUSION DOCUMENT. as required by REACH Article 48.

Substance Evaluation Conclusion document EC No SUBSTANCE EVALUATION CONCLUSION DOCUMENT. as required by REACH Article 48. SUBSTANCE EVALUATION CONCLUSION DOCUMENT as required by REACH Article 48 for Buta-1,3-diene EC No 203-450-8 CAS No 106-99-0 Evaluating Member State(s): Germany 22 October 2015 Evaluating Member State Competent

More information

Official Journal of the European Union. (Non-legislative acts) REGULATIONS

Official Journal of the European Union. (Non-legislative acts) REGULATIONS 21.2.2015 L 50/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) 2015/282 of 20 February 2015 amending Annexes VIII, IX and X to Regulation (EC) No 1907/2006 of the European Parliament

More information

Committee for Risk Assessment (RAC)

Committee for Risk Assessment (RAC) Committee for Risk Assessment (RAC) Opinion on the ECHA s draft review report on Evaluation of new scientific evidence concerning DINP and DIDP in relation to entry 52 of Annex XVII to Regulation (EC)

More information

SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING SAFETY DATA SHEET In accordance with 453/2010 and 1272/2008 (All references to EU regulations and directives are abbreviated into only the numeric term) Date of compilation 2012-06-01 SECTION 1: IDENTIFICATION

More information

Scientific Committee on Health and Environmental Risks SCHER

Scientific Committee on Health and Environmental Risks SCHER Scientific Committee on Health and Environmental Risks SCHER Critical review of any new evidence on the hazard profile, health effects, and human exposure to fluoride and the fluoridating agents of drinking

More information

GPS Safety Summary Sodium formate

GPS Safety Summary Sodium formate GPS Safety Summary Sodium formate Chemical Identity Name: Sodium formate CAS number: 141 53 7 Molecular formula: CHO 2 Na IUPAC name: sodium formate BASF brand names: Formic acid Structure O O Na + For

More information

Scientific Committee on Health and Environmental Risks SCHER

Scientific Committee on Health and Environmental Risks SCHER Scientific Committee on Health and Environmental Risks SCHER Critical review of any new evidence on the hazard profile, health effects, and human exposure to fluoride and the fluoridating agents of drinking

More information

EFSA Statement regarding the EU assessment of glyphosate and the socalled

EFSA Statement regarding the EU assessment of glyphosate and the socalled EFSA Statement regarding the EU assessment of glyphosate and the socalled Monsanto papers Background On 29 May 2017, EFSA received a request from the European Commission to produce a statement concerning

More information

Annex XV. 2,4 - Dinitrotoluene

Annex XV. 2,4 - Dinitrotoluene Annex XV 2,4 - Dinitrotoluene EC Number: 204-450-0 CAS Number: 121-14-2 Proposal for identification of a substance as a CMR cat 1 or 2, PBT, vpvb or a substance of an equivalent level of concern It is

More information

COMMISSION REGULATION (EU) / of XXX

COMMISSION REGULATION (EU) / of XXX EUROPEAN COMMISSION Brussels, XXX SANTE/11992/2017 Rev. 0 [ ](2017) XXX draft COMMISSION REGULATION (EU) / of XXX amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for

More information

COMMISSION REGULATION (EU) No /.. of XXX

COMMISSION REGULATION (EU) No /.. of XXX EUROPEAN COMMISSION Brussels, XXX [ ] [ ](2013) XXX draft COMMISSION REGULATION (EU) No /.. of XXX amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20

More information

Endocrine Disruptors

Endocrine Disruptors Endocrine Disruptors Dr. Bettina Hrdina-Zödl Institute for Plant Protection Products, Department of Toxicology Antragstellerkonferenz Vienna, 27.03.2014 www.ages.at Österreichische Agentur für Gesundheit

More information

Product Stewardship Summary

Product Stewardship Summary Product Stewardship Summary Dipropyleneglycol diacrylate General Statement Dipropyleneglycol diacrylate is a colorless liquid. It is a di-functional acrylate monomer that is known for its polymerization

More information

Opinion on. Classification of Musk ketone

Opinion on. Classification of Musk ketone EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Public Health and Risk Assessment C7 - Risk assessment SCIENTIFIC COMMITTEE ON HEALTH AND ENVIRONMENTAL RISKS SCHER

More information

Introduction to principles of toxicology and risk assessment

Introduction to principles of toxicology and risk assessment Introduction to principles of toxicology and risk assessment SEAC Training Helsinki, 29-30/06/2009 Kimmo Louekari Unit B4, Evaluation Disclaimer: This presentation does not represent ECHA s position on

More information

DEVELOPMENT OF THE CHROMIUM PUBLIC HEALTH GOAL

DEVELOPMENT OF THE CHROMIUM PUBLIC HEALTH GOAL DEVELOPMENT OF THE CHROMIUM PUBLIC HEALTH GOAL Robert A. Howd, Ph.D. Chief, Water Toxicology Unit Office of Environmental Health Hazard Assessment, California Environmental Protection Agency Oakland and

More information

PPH CERKAMED Safety Data Sheet - CHLORAXID 5,25% GEL

PPH CERKAMED Safety Data Sheet - CHLORAXID 5,25% GEL Page 1 of 6 SECTION 1: Identification of the substance/mixture and of the company/undertaking Product identifier: Product trade name: CHLORAXID 5,25% GEL Relevant identified uses of the substance or mixture:

More information

The regulatory landscape. The now and the not yet

The regulatory landscape. The now and the not yet The regulatory landscape The now and the not yet Perspectives Aims Promote common understanding Anticipate the coming changes Prepare for afternoon sessions Who governs pesticides? All EU legislation comes

More information

SAFETY DATA SHEET. Vertox Excel (HSE No 8708.)

SAFETY DATA SHEET. Vertox Excel (HSE No 8708.) SAFETY DATA SHEET Vertox Excel (HSE No 8708.). IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND THE COMPANY Product name Vertox Excel Company PelGar International Ltd Unit 3 Newman Lane Industrial Estate

More information

CLEANPRO APPLIANCE DESCALER

CLEANPRO APPLIANCE DESCALER SAFETY DATA SHEET ACCORDING TO 1907/2006/EC, ARTICLE 31 CLEANPRO APPLIANCE DESCALER SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1: PRODUCT IDENTIFIER Product Name

More information

Chemical food safety in the U.S. analysis of FDA s scientific basis for assessing chemical risk. Tom Neltner October 9, 2014

Chemical food safety in the U.S. analysis of FDA s scientific basis for assessing chemical risk. Tom Neltner October 9, 2014 Chemical food safety in the U.S. analysis of FDA s scientific basis for assessing chemical risk Tom Neltner October 9, 2014 Topics 1. Current focus of U.S. public interest community 2. Comparison of U.S.

More information

SAFETY DATA SHEET according to 1907/2006/EC, Article 31

SAFETY DATA SHEET according to 1907/2006/EC, Article 31 SAFETY DATA SHEET according to 197/26/EC, Article 31 Thermal Compound (S66C) SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Thermal

More information

Hydrated dolomitic lime

Hydrated dolomitic lime Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Evaluation of active substances Assessment Report Hydrated dolomitic lime Product Type 3 (Veterinary

More information

FAQs on bisphenol A in consumer products

FAQs on bisphenol A in consumer products FAQs on bisphenol A in consumer products Updated BfR FAQ, 19 February 2015 The substance bisphenol A is contained in polycarbonate products such as food and drink containers and bottles. Bisphenol A is

More information

SAFETY DATA SHEET. SECTION 1: Identification of the substance / mixture and of the company / undertaking.

SAFETY DATA SHEET. SECTION 1: Identification of the substance / mixture and of the company / undertaking. SAFETY DATA SHEET According to Regulation (EC) No. 1907/2006 (REACH) and its amendments. Date of issue: 01.01.2016 Version number: 5.0 Date of verification: 01.02.2017 SECTION 1: Identification of the

More information

1,1 - iminodipropan-2-ol

1,1 - iminodipropan-2-ol Possibility for MSCA Logo] SUBSTANCE EVALUATION CONCLUSION DOCUMENT as required by REACH Article 48 for 1,1 - iminodipropan-2-ol EC No 203-820-9 CAS No 110-97-4 Evaluating Member State(s): Czech Republic

More information

Eco Clear Shield - Polycarbonate

Eco Clear Shield - Polycarbonate SAFETY DATA SHEET Eco Clear Shield - Polycarbonate NON-Hazardous Substance, NON-Dangerous Goods Section 1: Identification 1.1 Product Identifier Polycarbonate coating Trade name : Eco Clear Shield - Polycarbonate

More information

SAFETY DATA SHEET THE BIG CHEESE RAT AND MOUSE KILLER ALL-WEATHER BLOCK BAIT. BAIT (HSE No.: 8794)

SAFETY DATA SHEET THE BIG CHEESE RAT AND MOUSE KILLER ALL-WEATHER BLOCK BAIT. BAIT (HSE No.: 8794) SAFETY DATA SHEET THE BIG CHEESE RAT AND MOUSE KILLER ALL-WEATHER BLOCK (HSE No.: 8794). IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND THE COMPANY Product name Company THE BIG CHEESE RAT AND MOUSE

More information

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL. Held on 20 September 2005 in Brussels MINUTES

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL. Held on 20 September 2005 in Brussels MINUTES EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C Public Health and Risk Assessment C7 Risk assessment Scientific Committee on Consumer Products SCIENTIFIC COMMITTEE ON

More information

Material Safety Data Sheet

Material Safety Data Sheet 1. MATERIAL AND COMPANY IDENTIFICATION Material Name : Uses : Air freshener Manufacturer/Supplier : SOPUS Products PO BOX 4427 Houston, TX 77210-4427 USA MSDS Request : 877-276-7285 Emergency Telephone

More information

PUBLIC CONSULTATION DOCUMENT

PUBLIC CONSULTATION DOCUMENT EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate C Public Health and Risk Assessment POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC PUBLIC CONSULTATION DOCUMENT

More information

HOW GOOD ARE VALIDATED METHODS TO PREDICT TOXICITY OF DIFFERENT TYPES OF SUBSTANCES AND PRODUCTS?

HOW GOOD ARE VALIDATED METHODS TO PREDICT TOXICITY OF DIFFERENT TYPES OF SUBSTANCES AND PRODUCTS? HOW GOOD ARE VALIDATED METHODS TO PREDICT TOXICITY OF DIFFERENT TYPES OF SUBSTANCES AND PRODUCTS? VERA ROGIERS Dept. Toxicology Vrije Universiteit Brussel Brussels, Belgium LAYOUT OF THE TALK CURRENT STATUS

More information

SAFETY DATA SHEET Cutan Luxury Shampoo, Conditioner & Bodywash

SAFETY DATA SHEET Cutan Luxury Shampoo, Conditioner & Bodywash SAFETY DATA SHEET SECTION 1: Identification: Product identifier and chemical identity Product identifier Product name Product No. 8040, SCB1L Details of the supplier of the safety data sheet Supplier DEB

More information

Recent Developments and Future Plans in the EFSA Assessments of Pesticides. Hermine Reich Pesticides Unit

Recent Developments and Future Plans in the EFSA Assessments of Pesticides. Hermine Reich Pesticides Unit Recent Developments and Future Plans in the EFSA Assessments of Pesticides Hermine Reich Pesticides Unit Pesticides Unit and Panel activities Scientific Panel on Plant Protection Product and their Residues

More information

HENNA POWDER Date: 1/18/17

HENNA POWDER Date: 1/18/17 HENNA POWDER Date: 1/18/17 1. Identification of the substance/preparation and the company TRADE NAME: UTILIZATION: SUPPLIER COMPANY IDENTIFICATION: Henna powder; Item# s: 9999500; 9999501; JAC9500 Ingredient

More information

Committee for Risk Assessment RAC. Opinion on new scientific evidence on the use of boric acid and borates in photographic applications by consumers

Committee for Risk Assessment RAC. Opinion on new scientific evidence on the use of boric acid and borates in photographic applications by consumers Committee for Risk Assessment RAC Opinion on new scientific evidence on the use of boric acid and borates in photographic applications by consumers ECHA/RAC/A77-O-0000001273-82-05/F Adopted 29 April 2010

More information

Annex to a news release

Annex to a news release Annex to ECHA News 1 (5) 15 June 2018 Annex to a news release Helsinki, 15 June 2018 SEAC adopted one restriction proposal Lead and its compounds in shot SEAC adopted its final opinion, in support of the

More information

Material Safety Data Sheet According to EU Regulation 1907/2006

Material Safety Data Sheet According to EU Regulation 1907/2006 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product Identifier Product Name Biological Definition INCI Name Synonyms & Trade Names Internal Product Code Theobroma

More information

SAFETY DATA SHEET. SECTION 1: Identification of the substance / mixture and of the company / undertaking.

SAFETY DATA SHEET. SECTION 1: Identification of the substance / mixture and of the company / undertaking. SAFETY DATA SHEET According to Regulation (EC) No. 1907/2006 (REACH) and its amendments. Date of issue: 01.02.2017 Version number: 2.0 Date of verification: 01.02.2017 SECTION 1: Identification of the

More information

Scientific Committee on Health and Environmental Risks SCHER. Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR

Scientific Committee on Health and Environmental Risks SCHER. Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR Scientific Committee on Health and Environmental Risks SCHER Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR Environmental impact and effect on antimicrobial resistance of four

More information

Committee for Risk Assessment RAC

Committee for Risk Assessment RAC ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON BENZOIC ACID Committee for Risk Assessment RAC Annex 2 Response s document (RCOM) to the Opinion proposing harmonised classification and labelling

More information

Opinion on the Risk from the Use of Diantimony Trioxide in Toys

Opinion on the Risk from the Use of Diantimony Trioxide in Toys Scientific Committee on Health and Environmental Risks SCHER Opinion on the Risk from the Use of Diantimony Trioxide in Toys The SCHER adopted this opinion at its 8th plenary on 1 July 2010 About the Scientific

More information